Early Rehab With VR for First-time Acute Stroke

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

38 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-04-12

Study Completion Date

2018-12-31

Brief Summary

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The goal of this clinical trial is to confirm the efficacy and feasibility of early rehabilitation combined with virtual reality training in patients following first-time acute stroke. The main questions it aims to answer are:

* The impact of virtual reality training on muscle strength;
* The impact of virtual reality training on functional recovery;
* The impact of virtual reality training on mood state.

Researchers will compare the experimental group, which received early rehabilitation combined with VR training, and the comparison group, which received only early rehabilitation, to see if VR training has clinical benefits when provided alongside early rehabilitation during hospitalization.

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Detailed Description

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Early rehabilitation has been shown to enhance outcomes for patients with first-time acute stroke. However, whether the addition of virtual reality (VR) training could further improve muscle strength, functional recovery, and mood state for these patients is unknown. Therefore, this study aimed to investigate the effectiveness of early rehabilitation combined with VR training in patients following first-time acute stroke. Patients with acute ischemic stroke will be selected and randomly assigned with a 1:1 randomization ratio to either the experimental group or the comparison group. Both groups received early rehabilitation, and the experimental group received extra VR training starting 24 hours to 3 days poststroke during the stay in the hospital. Muscle strength, functional status, and mood state will be collected before and after the intervention.

Conditions

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Stroke, Acute Acute Ischemic Stroke

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Participants were divided into two groups: the experimental group, which received early rehabilitation combined with VR training, and the comparison group, which received only early rehabilitation.

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Investigators Outcome Assessors

Study Groups

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experimental group

received early rehabilitation combined with VR training

Group Type EXPERIMENTAL

virtual reality training

Intervention Type BEHAVIORAL

The experimental group received five additional days of supervised VR training using a wireless sensor in a private room in the neurological care ward.

early rehabilitation

Intervention Type BEHAVIORAL

Five 60-minute sessions per week, was prescribed by a rehabilitation physician and performed by physical, occupational, and speech therapists from 3 to 6 days after admission.

comparison group

received only early rehabilitation

Group Type ACTIVE_COMPARATOR

early rehabilitation

Intervention Type BEHAVIORAL

Five 60-minute sessions per week, was prescribed by a rehabilitation physician and performed by physical, occupational, and speech therapists from 3 to 6 days after admission.

Interventions

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virtual reality training

The experimental group received five additional days of supervised VR training using a wireless sensor in a private room in the neurological care ward.

Intervention Type BEHAVIORAL

early rehabilitation

Five 60-minute sessions per week, was prescribed by a rehabilitation physician and performed by physical, occupational, and speech therapists from 3 to 6 days after admission.

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* first-time acute infarction (ischemic stroke);
* admission to the hospital within three days of stroke onset;
* able to communicate with verbal or nonverbal methods and understand Mandarin;
* had a disability that ranged from minimal to moderately severe disability and evaluated as 1-4 scores by the modified Rankin Scale (mRS);
* agree to be randomized.

Exclusion Criteria

* diagnosis of global aphasia, transient ischemic attack, visual or auditory impairment;
* mRS over 5 (severe disability: requires constant nursing care and attention, bedridden, incontinent);
* a history of cancer, end-stage renal disease with dialysis, dementia, mental health disorders (particularly major depression), based on both of medical records and assessments from the neurologist;
* being unable to participate due to other comorbid neurological and musculoskeletal conditions that produce moderate-to-severe physical disability;
* prolonged stay in hospital for over three weeks due to other medical diseases (e.g., myocardial infarction, septic shock, cancer) after admission or length of stay in hospital less than one week due to a decline to treatment and transferred to another hospital for further confirmation of diagnosis and other complementary or alternative therapies.

Minimum Eligible Age

20 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No